Table 4. Adjusted mean change from baseline to week 24 in SF-36 dimensions in patients with a high drinking risk level (MMRM, target efficacy population).
Short-Form health survey-36 (SF -36) Dimensions | Baseline | Change from Baseline to Week12 | Difference to Placebo | Change from Baseline to Week 24 | Difference to Placebo | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
N | Mean ± SD | N | Mean ± SE | Mean ± SE | 95% CI | p-value | N | Mean ± SE | Mean ± SE | 95% CI | p-value | ||
Bodily Pain | Placebo | 319 | 49.16 ± 10.66 | 279 | 0.73 ± 0.67 | 226 | 1.47 ± 0.70 | ||||||
Nalmefene | 316 | 49.85 ± 10.63 | 283 | 2.46 ± 0.66 | 1.73 ± 0.74 | [0.28; 3.17] | 0.0195 | 189 | 3.90 ± 0.72 | 2.43 ± 0.82 | [0.82; 4.05] | 0.0032 | |
General Health | Placebo | 318 | 43.84 ± 9.56 | 277 | 0.85 ± 0.56 | 224 | 1.46 ± 0.61 | ||||||
Nalmefene | 318 | 44.71 ± 9.53 | 283 | 2.47 ± 0.54 | 1.62 ± 0.60 | [0.45; 2.79] | 0.0066 | 189 | 3.82 ± 0.62 | 2.36 ± 0.71 | [0.96; 3.76] | 0.0010 | |
Mental Health | Placebo | 319 | 41.97 ± 11.35 | 280 | 2.01 ± 0.66 | 226 | 1.82 ± 0.70 | ||||||
Nalmefene | 316 | 41.66 ± 11.34 | 283 | 2.01 ± 0.66 | 1.61 ± 0.71 | [0.21; 3.01] | 0.0247 | 188 | 4.99 ± 0.72 | 3.17 ± 0.83 | [1.54; 4.79] | 0.0001 | |
Physical Functioning | Placebo | 317 | 50.95 ± 6.84 | 277 | 0.50 ± 0.43 | 223 | 1.03 ± 0.43 | ||||||
Nalmefene | 318 | 51.01 ± 7.01 | 281 | 1.59 ± 0.42 | 1.09 ± 0.47 | [0.16; 2.02] | 0.0216 | 187 | 2.24 ± 0.44 | 1.21 ± 0.49 | [0.24; 2.18] | 0.0142 | |
Role Emotional | Placebo | 316 | 42.36 ± 11.40 | 274 | 0.67 ± 0.71 | 221 | 2.33 ± 0.75 | ||||||
Nalmefene | 317 | 42.46 ± 11.46 | 280 | 3.25 ± 0.69 | 2.58 ± 0.77 | [1.06; 4.10] | 0.0009 | 188 | 4.66 ± 0.77 | 2.33 ± 0.89 | [0.58; 4.08] | 0.0093 | |
Role Physical | Placebo | 316 | 45.51 ± 9.2 | 273 | 0.94 ± 0.56 | 222 | 2.00 ± 0.60 | ||||||
Nalmefene | 317 | 45.89 ± 9.34 | 281 | 2.64 ± 0.54 | 1.71 ± 0.60 | [0.52; 2.89] | 0.0048 | 188 | 3.36 ± 0.61 | 1.36 ± 0.71 | [-0.04; 2.75] | 0.0561 | |
Social Functioning | Placebo | 319 | 43.33 ± 11.95 | 280 | 3.93 ± 0.61 | 226 | 3.20 ± 0.67 | ||||||
Nalmefene | 317 | 44.32 ± 10.62 | 284 | 2.09 ± 0.63 | 1.84 ± 0.69 | [0.49; 3.19] | 0.0078 | 189 | 5.36 ± 0.68 | 2.17 ± 0.79 | [0.62; 3.71] | 0.0061 | |
Vitality | Placebo | 319 | 47.04 ± 10.16 | 280 | 1.96 ± 0.60 | 226 | 1.97 ± 0.65 | ||||||
Nalmefene | 319 | 47.48 ± 9.56 | 283 | 3.55 ± 0.58 | 1.59 ± 0.64 | [0.33; 2.86] | 0.0135 | 188 | 4.30 ± 0.66 | 2.34 ± 0.77 | [0.83; 3.84] | 0.0024 |
MMRM: mixed model repeated measures.